An Interventional Efficacy and Safety, Phase 2, Double-blind, 3-arm Study to Investigate Orally Administered High/Low-dose Cepharanthine Compared With Placebo in Nonhospitalized Asymptomatic or Mild Adult Participants With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Time to viral clearance
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of high/low-dose cepharanthine for the Treatment of COVID-19 in asymptomatic and non-pneumonia mild adult participants with COVID-19 who do not need to be in the hospital, but in alternate care site.
详细描述
Screening participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
Patients will be randomized to one of three arms, all participants will receive standardized medical treatment (SMT) according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.
- low-dose experimental arm：cepharanthine 60mg/day + SMT
- high-dose experimental arm：cepharanthine 120mg/day + SMT
- placebo control arm：placebo + SMT
The primary outcome measure is the time to viral clearance which defined as first positive nucleic acid test to the date of the first negative test (in two consecutive point). SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value>35 for both ORF1ab and N gene was considered as negativity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 16 years old with all genders
- •SARS-CoV-2 positive（laboratory-confirmed reverse transcription polymerase chain reaction (RT PCR) test)
- •patient or immediate adult family member agrees to participate in this study and signs an informed consent form
- •asymptomatic or patients with mild covid-19 symptoms
- •confirmed SARS-CoV-2 infection within 5 days prior to randomization
排除标准
- •Confirmed SARS-CoV-2 infection within > 5 days prior to randomization
- •CT shows pneumonia on admission
- •diagnosed as severe or critical COVID-19 before intervention
- •has a history of chronic underlying disease and acute exacerbation of that underlying disease at the time of admission
- •Females who are pregnant or breastfeeding
研究组 & 干预措施
Low-dose cepharanthine + standardized medical treatment
Drug: cepharanthine (tablet) Day 1~5: 20mg, Q8H X 5 days + standardized medical treatment
干预措施: Cepharanthine (Drug)
High-dose cepharanthine + standardized medical treatment
Drug: cepharanthine (tablet) Day 1~5: 40mg, Q8H X 5 days + standardized medical treatment
干预措施: Cepharanthine (Drug)
placebo+standardized medical treatment
Drug: cepharanthine placebo (tablet) Day 1~5: placebo + standardized medical treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Time to viral clearance
时间窗: Day 1 through Day 28
The time to viral clearance was defined as first positive nucleic acid test（or randomization） to the date of the first negative test (in two consecutive point)
SARS-CoV-2 viral load
时间窗: Day 1 through Day 28
SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value\>35 for both ORF1ab and N gene was considered as negativity.
次要结局
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of CEP relative to placebo.(Day 1 through Day 28)
- Proportion of participants developing COVID-19 pneumonia(Day 1 through Day 28)
- Proportion of participants developing severe pneumonia(Day 1 through Day 28)
- Number of days from the onset of fever until the temperature drops below 37.3°C(Day 1 through Day 28)
研究者
Hai Li
professor of department of gastroenterological division, Renji Hospital
Shanghai Jiao Tong University School of Medicine